Hepatera, a Russian biotech company and part of Maxwell Biotech Venture Fund's portfolio, has announced today the inclusion of the first three patients with chronic hepatitis B in the clinical trial phase Ib-IIa of Myrcludex B. Hepatera was founded in 2011 and is focused on the development of innovative therapeutics for the treatment of liver diseases. The study is being conducted in major Russian specialized clinical centers and its results are expected in the end of 2013.
Hepatera is a resident of the Skolkovo Biomedical Cluster and has been financed by Maxwell Biotech Venture Fund. Myrcludex B, an innovative drug candidate for the treatment of chronic viral hepatitis B and D, is developed in close cooperation with a German biotech company MYR GmbH, a portfolio company of High-Tech Grunderfonds (HTGF), one of Europe's largest venture funds.
Despite the widespread introduction of vaccination, chronic hepatitis B remains an unsolved health problem. According to the WHO close to 2 billion people in the world are carriers of HBV, of which about 400 million are chronically ill. Every year approximately 50 million people get infected with HBV and almost 2 million people die from liver conditions caused by this infection. Co-infection with HDV which is diagnosed in about 5% of cases increases the severity of the disease doubling the frequency of complications and mortality rate, compared to monoinfection. To date there are limited options to treat the HDV co-infection.
"It is very important for us that we take part in such a large international project and have the opportunity to be the first center to evaluate the effectiveness of the Myrcludex in patients. We hope that the positive results of this clinical trial will allow the company to continue the development of the drug, which offers a new approach to the treatment of patients with hepatitis B, and will be able to significantly improve and simplify the existing treatment regimen," said Elena Volchkova, consultant for "Infectious Clinical Hospital N2" of the Moscow Department of Health, Doctor of Medical Science, Head of the Department of Infectious Diseases of the Sechenov First Moscow State University, principal investigator.
"We are excited to see that Myrcludex has now moved into the clinical study in patients who might benefit from the treatment. In this study we have a particular emphasis on safety, but also looking at HBsAg levels which remain unaffected by current standard treatment regimens in the majority of patients. With the HBV receptor identified now, we hope that the results will boost the field and deliver a milestone in combating this important disease," said Alexander Alexandrov, Chief Scientific Officer at MYR GmbH.
About Myrcludex B
The idea for Myrcludex B was developed within two renowned research institutions in Europe, the French National Institute of Health and Medical Research (INSERM) and University of Heidelberg in Germany. Myrcludex inhibits the essential HBV receptor on the liver cell surface and thus prevents the infection of the healthy cells and viral spreading in the liver. Entry inhibitors are well established in the treatment of viral infections (Celsentri(R), Relenza(R)). During the chronic HBV infection new liver cells constantly become infected. By the treatment with an entry inhibitor, this new infection may be inhibited and the number of the infected cells should significantly decline within a few months. The immune system could then regain the control over the infection and the long-term treatment with viral replication inhibitors could be omitted or significantly shortened. HDV is using the HBV receptor to get into the cell. As expected, Myrcludex has shown great efficacy against HDV in preclinical tests. Clinical trial Phase Ia conducted by MYR in Germany in healthy volunteers showed good safety and tolerability.
MYR GmbH, a biotechnology company located in Burgwedel near Hannover was founded in 2010 and holds world-wide exclusive product rights for Myrcludex. The company has successfully conducted preclinical development and a Phase 1 clinical trial of Myrcludex. Currently, MYR is focused on the coordination of the network of academic partners and vendors involved in Myrcludex development and is collaborating with Hepatera Ltd in the proof of concept clinical trial.
Hepatera, Ltd is a private biotechnology company, founded in 2011 with the mission to develop and launch into the Russian market innovative products for the treatment of liver diseases. Hepatera has been a resident of Skolkovo Biomedical Cluster since December 2011. The first product (Myrcludex B) is aimed at treatment of chronic viral hepatitis B and D, and is developed in close cooperation with a German biotech company MYR GmbH, a portfolio company of High-Tech Grunderfonds (HTGF), one of Europe's largest venture funds.
About Maxwell Biotech Venture Fund
Maxwell Biotech Venture Fund (MBVF) is one of the first Russian funds dedicated to investments in the life science sector and has been formed with the participation of Russian Venture Company (RVC). MBVF relies on an experienced international team of managers and financial and industry experts and has offices in Moscow and Boston. MBVF is investing in product development companies specializing in specific therapeutic areas or medical devices categories. To date, MBVF has invested in OncoMax (oncology), NeuroMax (CNS), MetaMax (oncology & metabolic diseases), Infectex (infectious diseases), CardioNova (cardiovascular diseases), Hepatera (liver diseases), Osteros Biomedica (cancer-induced bone diseases), Eleventa (inflammatory respiratory diseases) and Photonics (novel lasers for medicine and dentistry). Products in these companies originated either from Russian scientists or were licensed from international biopharma companies.